Abstract
PurposeOur previously study showed that recombinant human endostatin (Endostar) combined with chemotherapy had significant activity to increase the mPFS in patients with advanced sarcomas with tolerable side effects. However, the small cohort size and short follow-up time made it difficult to screen sensitive sarcoma subtypes and determine whether there is an overall survival benefit. With the largest sarcoma cohort to our knowledge, we try to confirm the efficacy and safety of chemotherapy combined with Endostar in stage IV sarcomas, with the specific purpose of finding out the sensitive sarcoma types for this combined treatment.MethodsAfter the exclusion of ineligible patients, 156 patients with stage IV bone and soft tissue sarcomas were included in this study according to the inclusion criteria.ResultsBy the end of follow-up, the ORR was 10.7% (9/84) vs 1.4% (1/72) (p=0.041), the DCR was 26.2% (22/84) vs 5.6% (4/72) (p=0.001) in the combined group and chemotherapy group, respectively. The mPFS of combined group was significantly longer than the chemotherapy group (10.42 vs 6.87 months, p=0.003). The mOS were 26.84 months and 23.56 months, without significant difference (p= 0.481). In osteogenic sarcoma, there was no statistically significant difference in the mPFS between the two groups (p=0.59), while in the soft tissue sarcoma, the mPFS in the combined group was significantly higher than that of the chemotherapy group (11.27 vs 8.05 months, p=0.004). Specifically, undifferentiated polymorphic sarcoma (UPS) was the possible sarcoma subtypes that benefited from the combined therapy. For the 38 UPS patients (28 patients in the combined group and 10 patients in the chemotherapy group), the mPFS in the combined group was up to 14.88 months, while it was only 7.1 months in the chemotherapy group, with a significant difference (p=0.006). The most common adverse events in the combined group were myelosuppression, gastrointestinal reactions and abnormal liver function, without significant difference in two groups.ConclusionChemotherapy plus Endostar could prolong mPFS and improve ORR and DCR in patients with stage IV soft tissue sarcoma, suggesting that the combined therapy could improve the patient prognosis in soft tissue sarcomas, especially the UPS patients.
Highlights
Sarcomas are highly malignant tumors with complex pathological types and large heterogeneity and are mainly divided into two major categories: osteogenic sarcoma and soft tissue sarcoma, both of which have a poor prognosis [1,2,3]
Doxorubicin combined with immunotherapy, such as pembrolizumab, has Abbreviations: UPS, undifferentiated pleomorphic sarcoma; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; ORR, objective response rate; DCR, disease control rate; mPFS, median progression-free survival; mOS, median overall survival; AJCC, American Joint Committee on Cancer; MPNST, malignant peripheral nerve sheath tumor; AI, doxorubicin+ ifosfamide; T10, methotrexate+ cisplatin+ doxorubicin; GT, gemcitabine+ paclitaxel; MAID, mesna + doxorubicin+ ifosfamide+ dacarbazine; CAV, cyclophosphamide+ doxorubicin+ vincristine; IE, ifosfamide + etoposide
According to the treatment methods, the patients were divided into two groups: 84 were included in the Endostar combined with chemotherapy group (Figure 1C), and 72 were included in the traditional chemotherapy group (Figure 1D)
Summary
Sarcomas are highly malignant tumors with complex pathological types and large heterogeneity and are mainly divided into two major categories: osteogenic sarcoma and soft tissue sarcoma, both of which have a poor prognosis [1,2,3]. Despite advances in surgical techniques, the prognosis of patients with bone and soft tissue sarcoma has not improved significantly in recent years. There have been an increasing number of clinical trials evaluating the value of chemotherapy combined with other therapies in patients with sarcoma. Doxorubicin combined with immunotherapy, such as pembrolizumab, has Abbreviations: UPS, undifferentiated pleomorphic sarcoma; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; ORR, objective response rate; DCR, disease control rate; mPFS, median progression-free survival; mOS, median overall survival; AJCC, American Joint Committee on Cancer; MPNST, malignant peripheral nerve sheath tumor; AI, doxorubicin+ ifosfamide; T10, methotrexate+ cisplatin+ doxorubicin; GT, gemcitabine+ paclitaxel; MAID, mesna + doxorubicin+ ifosfamide+ dacarbazine; CAV, cyclophosphamide+ doxorubicin+ vincristine; IE, ifosfamide + etoposide
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